The questions for “make vs. buy" raised by Bristol-Myers Squibb’s Christopher Sinko, SVP and Head of Product Development, are news because of this: Sinko reaffirms for us they remain cemented within the otherwise changing dynamics impacting drug development and manufacturing outsourcing decisions.
Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.
It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.
Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.
Are you up to the task of bringing a biologic to market? Do you have a strategy and plan in place? Explore some of the questions to consider in order to map out a successful pathway and avoid pitfalls.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
When conducting trials of biologics, the number of considerations to evaluate within the clinical trial supply chain can be daunting. Keeping investigational products at the right temperature and environmental conditions takes careful coordination of resources and, when required, tight integration with an experienced vendor.
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.
This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.
This application note reports on the initial experience of Thermo Scientific Nunc High Density Cell Factory systems, which enable large-scale production of adherent cells.
As today’s information-craving customers force the life sciences industry to change their sales and marketing model, innovative customer engagement models are sought as a revenue-generation lever. Message reach and frequency no longer equate to sales. Now it’s about building and sustaining customer loyalty by delivering value. Top-line and market share growth are perpetuated by the quality of customer engagements.
Moving from brand message to customer needs requires sales, marketing and technology teams to revise their strategies. To implement this new communication approach, life sciences companies will face some key challenges. Understanding these core challenges is the first step toward customer communication transformation, a journey that leads to growth, cost reductions and enhanced technology value.
You would expect a room full of communications, marketing and public relations professionals to be exuberant in their discussion of how to deliver the company message across platforms and generally boast about their brands. While some of that did take place at the 3rd Annual Life Science Brand Reputation and Communications Conference in Atlanta (February 20-21), a lot of the discussion focused on FDA regulations and SEC concerns, and the checks and balances applied to patient, media and investor communications by internal legal and investor relations departments.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
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Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
A Powerful Choice: Selecting Potency Assays for Biologics. Will it be animal models, cells, or chemical assays? The decision can make or break product success.
By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.
Small and virtual biotech and pharmaceutical companies rely heavily on partners to advance their development programs. This article offers insider tips for spotting when quality culture has gone bad.
If you have decided to add capacity in-house, you need to consider which location enables you to meet demand. Having knowledge of the local operating environment and regulatory considerations is vital.
There is no shortage of guidance for conducting extractables and leachables studies. The trick is aligning standards that overlap.
